Gynaecologic Organ Segmentation and Motion Tracking Using Ultrasound

Cervical Cancer Clinical Trial

— GENIUS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02503917
• Other study ID #: CCR4342
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2015
• Last updated: May 20, 2016
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: Royal Marsden NHS Foundation Trust
• Contact: Julie Curtis
• Phone: 02086713873
• Email: julie.curtis[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This study will establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images using both healthy volunteer and cervical patient cohorts. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

Description:

Radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. In the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. There are sophisticated radiation delivery techniques (known as IMRT and VMAT) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. However, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. The uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. Currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. Ultrasound is a promising way to overcome this problem.

Ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. We wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. This will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteer cohort: Healthy female adult volunteers

• patient volunteer cohort: Patients receiving radiotherapy for cervical cancer who will receive a planning CT scan and daily CBCT scanning as part of their treatment.

Exclusion Criteria:

• both cohorts: Women who have received hysterectomies and women who are pregnant at the time of the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ultrasound scans with dice similarity coefficient (DSC) of >0.90 between algorithm-derived contour and ground-truth contour	The DSC between the ground truth contour and the algorithm derived contour will indicate the accuracy of the segmentation algorithm.	DSC calculated at 24 time points for each healthy volunteer (3 days)	No
Primary	Coefficient of variation between of expert-drawn contours on ultrasound and expert-drawn contours on CBCT	A small COV will indicate greater clinician/expert confidence in segmenting the uterus	COV calculated at a minimum of 3 time points during 6 weeks that the patient is receiving radiation therapy	No
Secondary	Bland-Altman plot (healthy volunteer cohort)	Used to describe the level of agreement between MR and ultrasound images of the uterus.	1 day	No
Secondary	Uterine center of mass displacement on ultrasound (healthy volunteer cohort)	Assess both inter- and intra- fractional motion of the uterus.	3 days	No
Secondary	Expert confidence scores for each imaging modality (ultrasound and MR) (healthy volunteer cohort)	Determine if uterine segmentation on ultrasound receives acceptable confidence score compared with MR	from data collected over 3 days	No
Secondary	Bland-Altman plot (patient volunteer cohort)	describe level of agreement among the COV, circularity index, volume, and centre of mass position betweeen ultrasound, CT, and CBCT.	6 weeks	No
Secondary	Expert confidence scores for each imaging modality (ultrasound, CT, and CBCT) (patient volunteer cohort)	Determine if uterine segmentation on ultrasound receives greater confidence score compared with CT and CBCT.	from data collected over 6 weeks	No